State Food and drug administration issues on-site verification plan for medical devices
Medical network, Nov. 25, involves medical device coding, in vitro diagnostic reagents, sales labels, product traceability, commissioned production and other aspects.
On October 22, according to the information on the official website of the State Food and drug administration, in order to further strengthen the verification of the medical device registration quality management system and improve the level of the medical device registration management, the State Food and Drug Administration organized the drafting of the guidelines for the on-site verification of the medical device registration quality management system (Draft for comments) (see the annex), which is now open to the public for comments.
1、 Purpose and basis
In order to standardize the on-site verification of the medical device registration quality management system, strengthen the connection between the review and verification, and ensure the quality of the on-site verification of the medical device registration, this guide is formulated in accordance with the administrative measures for the registration of medical devices, the administrative measures for the registration of in vitro diagnostic reagents, the management specification for the production quality of medical devices and its appendix.
2、 Scope of application
This guide is applicable to the on-site verification of the second and third class medical device registration quality management systems by the medical device regulatory authorities.
3、 Basic principles
（1） This guide should be used on the premise of following the "medical device production quality management specification" and its supporting documents.
（2） It is necessary to focus on the "design and development", "procurement", "production management", "quality control" and other contents related to product development and production, as well as the authenticity verification requirements, in combination with the registration application materials.
（3） The applicant for medical device registration (hereinafter referred to as the applicant) shall establish and maintain an effective quality management system suitable for the product realization process, be responsible for the whole life cycle management of medical device, ensure the authenticity, reliability, integrity and traceability of data in the design, development, production and other processes, and be consistent with the registration application data.
（4） The conclusion of the verification shall be determined in accordance with the requirements of the procedures for verification of the registration quality management system for class III medical devices in China (Provisional).
4、 Key verification contents
（1） Organization and personnel
Medical device design and development personnel shall be equipped to meet the product requirements. Personnel shall have appropriate education background, professional knowledge and working skills for the developed products.
（2） Plant, facilities and equipment
1. Product research and development shall be carried out in appropriate plants and facilities. The plants and facilities used for registration inspection and clinical trial sample production shall meet the quality control requirements of research and development and production products.
2. It shall be equipped with places, equipment and instruments suitable for the research project, including production and testing equipment for trial production of samples used for registration and application for inspection and clinical trials, and the equipment capacity shall meet the requirements for trial production of samples.
3. The production address applying for on-site verification of the registered quality management system shall retain the factory building and facilities for trial production of samples for registration inspection and clinical trial, and meet the requirements of trial production quantity, model and specification.
（3） Document management
1. For the entrusted products, the applicant shall ensure that the documents of the entrusted party meet the relevant requirements of the quality management system of the entrusting party, and effectively control, including all the R & D materials and technical documents handed over.
2. The original design and development data shall be included in the document management. The applicant shall keep the research data verified after the product development or technology transfer to ensure the authenticity, integrity and traceability of the data; in addition to the test data directly output, the applicant shall also keep the auxiliary records during the development process, such as the main material acquisition records, instrument and equipment use records, weighing records, preparation records, etc., to increase the traceability of the development process.
（4） Design and development
The design and development documents of medical devices shall be derived from the relevant documents of design and development review, verification, confirmation and design conversion activities, including the design and development procedures, development plans and established records, and shall ensure the traceability of the final output process and related activities of previous design and development.
1. The basis of design and development input shall include laws and regulations, national standards, industry standards, domestic and foreign guide documents, national reference products, international reference products, standard products or technical indicators of similar products, and the input shall include clear scope of application, clinical significance and application value.
2. The design and development output shall meet the needs of users and product design, and shall pay attention to the scope of application, functionality, safety, effectiveness and quality controllability of products;
Passive medical devices should focus on the requirements of raw material components, physical and chemical properties and biocompatibility of raw materials or medical grade requirements, as well as the performance requirements that raw materials should meet when non disposable sterile products are re sterilized, and the research results that can withstand re sterilization.
In vitro diagnostic reagents should focus on the supplier (manufacturer) information of all raw materials, unique traceability information (such as clone number, nucleic acid sequence, product traceability code, etc.), quality control requirements and methods of main raw materials, process formula, manufacturer information and quality control requirements of packaging materials directly contacting with products, preparation methods and quality control methods of quality control products, so as to And required equipment and instruments. In addition, the determination process, determination basis and experimental data of production process and reaction system, such as solution preparation, antibody coating process and experimental process, shall be reviewed.
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